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AliveCor KardiaMobile 6L User Manual

AliveCor KardiaMobile 6L
19 pages
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AliveCor is a registered trademark of AliveCor, Inc.
Instructions for Use (IFU)
for
KardiaMobile 6L (AC-019)
19LB01.02
AliveCor, Inc.
444 Castro Street,
Mountain View, CA 94041, USA
© AliveCor, Inc. 2020

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AliveCor KardiaMobile 6L Specifications

General IconGeneral
Number of Leads6
ConnectivityBluetooth
CompatibilityiOS and Android devices
BatteryCR2016 coin cell battery
FDA ClearedYes
Device TypePersonal ECG Monitor
Detection CapabilitiesAtrial Fibrillation, Bradycardia, Tachycardia, Normal Sinus Rhythm
App RequiredYes (Kardia App)
Data Recording30-second ECG recordings

Summary

Guide to Parts

Warnings

Cautions

Indications For Use

Features & Functionality

Setting Up Your KardiaMobile 6L Hardware

Recording a Single-Lead EKG

Recording a Six-Lead EKG

EKG Analysis

Clinical Safety and Performance

Maintenance

Electromagnetic & Other Interferences

FCC Compliance

Industry Canada Compliance

Troubleshooting

Device Not Working Troubleshooting

Six-Lead EKG Selection Troubleshooting

Upside-Down EKG Troubleshooting

Electrical Safety

Electromagnetic Immunity Guidance

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